Radar · device · signal

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NRecall or enforcement action

Complete coverage checks before an early-window claim.

Statistical status

No screen yet

Receipt-date counts have not been screened.

Evidence score

—

Research priority weight, not a probability of causation or recovery.

Missing: none recorded

Competition

unknown

Observed in monitored channels only. Unknown is not zero.

Coverage unknown. Early-window label is blocked.

What changed

Qualitative review · notice
Enforcement report. This is a product action, not an injury count. The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or or
10/09/2026 · A recall may not involve the injury later investigated.
Read the source

Receipt dates are the reporting screen. Event dates are a separate, lag-sensitive series. They are not added together.

Basis	Window	Covered days	Reports	Expected	Fold	Complete

Unknown. Court and RECAP collectors are not in this release. Do not read a blank docket as zero lawsuits.

No firm pages or ad notes. Competition stays unknown until the panel records one.